QA Specialist
About The Position
The Quality Assurance Specialist is responsible for supporting and executing Quality Control (QC) and Quality Assurance (QA) activities across the Avacare Clinical Research network. This role ensures that clinical operations, regulatory documentation, and site processes meet internal quality standards, Good Clinical Practice (GCP) requirements, and applicable regulatory guidelines. The Quality Specialist works closely with site teams, study staff, and the Manager of Site Quality Management to proactively identify quality risks, implement corrective actions, promote audit readiness and drive continuous quality improvement.
Requirements
- Bachelor’s degree in health sciences with 1-3 years relevant experience or High School Diploma with 5+ years relevant experience
- Working knowledge of GCP, ICH guidelines, and general clinical research operations.
- Strong attention to detail and commitment to data accuracy and compliance.
- Excellent communication, documentation, and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Ability to work independently and collaboratively across sites and teams.
- Proficient in technology, including Microsoft Office suite and SharePoint
- Ability to think critically and analyze study and site context to anticipate risk.
Responsibilities
- Conduct internal audits of site processes, study documentation, and source records to ensure compliance with GCP, protocols, SOPs, and regulatory requirements.
- Assist in developing and maintaining study-level risk assessments
- Identify quality gaps, root causes, and trends; support Corrective and Preventive Action (CAPA) development and implementation.
- Participate in and/or support sponsor audits and regulatory inspections, either in person or remotely
- Maintain quality documentation including audit reports, training records, deviation logs, CAPA plans, and Quality metrics.
- Perform routine QC checks on informed consent documentation, AEs/SAEs, source records, investigational product accountability, protocol deviations, and data entry.
- Verify accuracy and completeness of clinical trial documentation.
- Conduct ongoing review of study workflows to confirm adherence to protocol requirements and internal SOPs.
- Collaborate with site staff to ensure that QC findings are understood, corrected, and prevented in future workflows.
- Track and report key quality metrics and trends to the Manager of Site Quality Management.
- Contribute to process improvements aimed at enhancing data integrity, subject safety, and regulatory compliance.
- Lead or support quality-related projects as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
